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Zolpidem tartrate - Generic Drug Details

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Zolpidem tartrate is the generic ingredient in seven branded drugs marketed by Torrent Pharms, Sandoz, Sanofi Aventis Us, Par Form, Teva, Biovail Labs Intl, Aurobindo Pharma, Roxane, Mylan Pharms Inc, Vintage, Sandoz Inc, Wockhardt, Purdue Pharma, Hikma, Synthon Pharms, Anchen Pharms, Actavis Labs Fl Inc, Sun Pharm Inds Ltd, Sun Pharm Inds Inc, Vivimed Labs, Apotex Inc, Lupin Ltd, Watson Labs, Mylan, Actavis Elizabeth, Invagen Pharms, Dr Reddys Labs Ltd, Cipla Ltd, Sun Pharm Inds, Carlsbad, Amherst Pharms Llc, Meda Pharms, and Novel Labs Inc, and is included in thirty-seven NDAs. There are ten patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and fifteen patent family members in thirty-five countries.

There are thirty-one drug master file entries for zolpidem tartrate. Sixty-five suppliers are listed for this compound.

Summary for Generic Name: zolpidem tartrate

Tradenames:7
Patents:10
Applicants:33
NDAs:37
Drug Master File Entries: see list31
Suppliers / Packaging: see list65
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: zolpidem tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET;ORAL077773-001Apr 23, 2007DISCNNo► subscribe► subscribe
Purdue Pharma
INTERMEZZO
zolpidem tartrate
TABLET;SUBLINGUAL022328-001Nov 23, 2011RXNo7,658,945► subscribeY ► subscribe
Hikma
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET;ORAL078129-002Apr 30, 2008DISCNNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: zolpidem tartrate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
AMBIEN
zolpidem tartrate
TABLET;ORAL019908-001Dec 16, 19924,382,938*PED► subscribe
Sanofi Aventis Us
AMBIEN CR
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL021774-002Sep 2, 20054,382,938*PED► subscribe
Sanofi Aventis Us
AMBIEN CR
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL021774-001Sep 2, 20054,382,938*PED► subscribe
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Non-Orange Book Patents for Generic Ingredient: zolpidem tartrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,078,816Buccal, polar and non-polar spray containing ondansetron► subscribe
8,454,996Pharmaceutical composition for the treatment of acute disorders► subscribe
6,977,070 Buccal, polar and non-polar spray or capsule containing drugs for treating disorders of the central nervous system► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: zolpidem tartrate

Country Document Number Estimated Expiration
Portugal2236132► subscribe
China101198327► subscribe
BrazilPI0507733► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ZOLPIDEM TARTRATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00004Denmark► subscribePRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
636Luxembourg► subscribePRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
00714Netherlands► subscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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